Third World Network, November 20, 2015. Geneva – A socioeconomic impact study on substandard/spurious/ falsely-labelled/falsified/counterfeit (SSFFC) medical products by the World Health Organization secretariat comes across as propaganda findings, according to several developing countries.

The study, based on a United States proposal and which is currently in progress, makes an estimate of annual purchase of substandard and falsified medicines at USD 50 billion.

This figure of USD 50 billion is arrived at on the basis of 13.7% of estimated prevalence of substandard and falsified medicines.

These findings are contained in a one-page executive summary shared with WHO Member States that does not reveal the methodology used to reach figures on prevalence. The fourth meeting of the WHO Member States Mechanism (MSM) on SSFFC discussed this on 19November in Geneva. The MSM meeting concludes on 20November.

(The MSM was established through a World Health Assembly resolution to guide WHO’s activities on quality, safety and efficacy of medicines without conflating it with intellectual property enforcement.)

The USD 50 billion is calculated using the prevalence data that the executive summary states as follows: “… if the 13.7% prevalence figure is applied to the overall medicines market in low and middle income countries.”

The estimation of prevalence of substandard and falsified medicines is reached using data from 97 publicly available peer reviewed field studies. On limitations of the study the executive summary states: “with the limitation that most of the studies were conducted in Africa and Asia, and predominantly on anti-malarial and antibiotic medicine …”

It further states, “Methodological challenges prevent the extrapolation of this figure beyond the scope of data, particularly given the gaps in the literature from certain regions (e.g. higher income countries) and therapeutic classes (e.g. medicines for non-communicable diseases).

Interestingly, with all these limitations the executive summary concludes that, “it is nonetheless possible to estimate the minimum size of annual purchases of substandard and falsified medicines at USS 50 billion”.

The executive summary also states that “based on the aggregated data form field studies, out of specification (one type of substandard) appears to be a significant problem, although falsified medicines have also been reported”. However the document provides only the USD 50 billion figure as annual purchases of substandard and falsified medicines. It does not give any breakdown of substandard and falsified medicines.

The executive summary also does not provide any details of the 97 publicly available peer reviewed studies used for the initial findings. It is not even clear at this point if the Secretariat and authors of the study would provide enough details about these studies.

Third World Network (TWN) learned that an expert meeting was organised on 11-12 November to discuss the study. The executive summary was shared with the experts only on 12November. As a result there was only a little discussion on the executive summary at the experts meeting. The note of record of the meeting does not reflect any discussion on the USD 50 billion. The one-page executive summary was shared with Member States’ missions in Geneva only on 18 November, which scuttled all possibilities of seeking specialist opinion from capitals.

Irrespective of the lack of time to study the executive summary many Member States especially Brazil and Argentina questioning the findings at the MSM meeting on 19 November. A delegate told TWN that the discussion on the topic took more than two and a half hours during the afternoon session from 2 to 5 pm.

Member States asked the lead author of the study, Mr. David Evans, to explain the methodology to reach the USD 50 billion figure. Member States also stressed the need to explain the methodology of the study and its limitations. Further, questions were also raised on the feasibility of using data from different sources especially for extrapolation purposes. Member States also asked about the criteria for the inclusion and exclusion of data.

Many Member States repeated their demand to fully exclude private data and data of studies financed by the private sector including the pharmaceutical industry. Queries were made to the lead author about the definition of substandard medicine and falsified medicine.

Suggestions also came up to list as annexures assumptions and limitations on the data used for the study. One Member State pointed out that SSFFC is a global issue and not the problem of developing countries only.

The opinion of the WHO legal advisor was sought on whether the study needs the approval of the MSM for publication. The legal advisor responded that there is no such practice of seeking approval of governing bodies to publish technical work.

However, a new time line has been agreed to finalise the study. According to the new time line the draft will be shared towards the end of March 2016 for the comments of Member States. The final document would be ready by June 2016 after incorporating the comments from Member States.

Several Member States told TWN that they are very concerned that the study would be used for propaganda purposes to push an intellectual property (IP) enforcement agenda by conflating quality, safety and efficacy of medicines with IP.

In the past WHO, citing data from industry sources, declared that the prevalence of counterfeit in developing countries was 10% to 30 %, with selected states of the former Soviet Union having a prevalence of more than 20%.

In 2006 a WHO–IMPACT document titled “Counterfeit: An Update on Estimate” stated: “… many developing countries of Africa, parts of Asia, and parts of Latin America have areas where more that 30% of the medicines on sale can be counterfeit. Other developing markets, however, have less than 10%; overall, a reasonable estimate is between 10% and 30%; – many of the former Soviet republics have a proportion of counterfeit medicines which is above 20% of market value – this falls into the developing country range.” (http://www.who.int/medicines/services/counterfeit/impact/TheNewEstimatesCounterfeit.pdf)

(IMPACT is the International Medical Product Anti-Counterfeit Taskforce, a multi-stakeholder platform for intellectual property enforcement dominated by pharmaceutical industry interests. In 2011 the IMPACT secretariat was shifted out of WHO due to opposition from many Member States.)

As developing country Member States started questioning the source of data and methodology the WHO Secretariat had to back out from this propaganda data. In 2008 the WHO Secretariat stated, “It is impossible to obtain a precise estimate of the proportion of counterfeit medical products on national markets” (http://apps.who.int/gb/ebwha/pdf_files/EB124/B124_14-en.pdf). Then it gave other statistics to defend its IP enforcement agenda.

The above document stated: “ … the number of incidents detected in 2007 increased to more than 1500, that is more than four cases a day. Even minor cases concern at least one production batch, which amounts to thousands of tablets. The 2007 figure represents roughly a 20% increase over that for 2006 and a 10-fold increase over 2000”.

Of late both assertions turn out to be wrong. WHO had carried out two studies that were published in 2011. The first study looked at selected antimalarial medicines in six Sub-Saharan Africa countries. The second study looked at the quality of anti-tuberculosis medicines circulating in selected former Soviet Republics.

The first study collected 935 samples and after various verifications selected 306 samples for laboratory testing. Finally only 267 samples were fully tested. The finding states: ‘… 28.5% of them failed to comply with specifications. Although non-compliance with pre-established criteria cannot be directly related to a risk for patients’ health, such a high failure rate indicates a substantial problem in the quality of antimalarials present in distribution channels. Focusing only on extreme deviations from specifications (as defined in this report), which are likely to be associated with health implications, the failure rate reached 11.6%.”

Further the study stated: “Eight of 29 samples failing content testing (including seven of 22 ACTs) deviated from the declared content by more than 20%. Two samples in the survey were missing one of the APIs altogether (one ACT and one SP). It was not investigated whether these samples were counterfeits. However, one of them was suspicious, as it contained only 9% of the second API (active pharmaceutical ingredient) and tablet appearance differed from another sample from the same manufacturer. However, it can be concluded that, despite a high proportion of substandard samples collected in this survey, the proportion of medicines missing active ingredients was low”.

(ACT refers to Artemisinin-based combination therapy while SP is Sulfadoxine/pyrimethamine.)

Regarding counterfeit the studystated: “One of the objectives proposed in the survey protocol was to estimate the proportion of counterfeit ACT and SP products at different points of the regulated and informal distribution system. However, it was recognized that confirmation of substandard products as counterfeits is a very complex activity going beyond the scope of quality testing and therefore could not be fully executed.”

Thus WHO’s claim on provenance of counterfeit found in Africa has little evidence at least in the area of antimalarials.

The second study found “overall 33 samples (11.3%) failed to meet the specifications set for the survey. Focusing only on extreme deviations from specifications, the total failure rate reached 1.0%”. Regarding counterfeit it stated, “No sample was suspected to be of a spurious, falsely-labelled, falsified or counterfeit product.”

Thus the studies do not provide any indication to support the publicly circulated information of scale of counterfeit medicines.

In 2012 WHO initiated a project on surveillance and monitoring of SSFFC medical products. This project was initiated with financial assistance from European Member States. The project is using the terminology SSFFC medical products without any shared understanding on these terms viz. substandard, spurious, falsified, falsely labelled and counterfeit medicines. According to the Secretariat “as of September 2015, 826 suspected SSFFC medical products have been reported from 78 Member States”. (http://www.who.int/medicines/regulation/ssffc/surveillance/en/)

These alerts need to be assessed and validated through independent analyses. These 826 alerts in the last three years are far below what WHO stated in 2008 i.e. more than 4 alerts per day. The surveillance and monitoring project was started in 2012.

Diverted medical products are defined as “genuine Quality medical products diverted from intended supply route. No guarantee of standards of distribution and storage”.

Stolen medical products are defined as “Quality medical products or packaging that have been stolen from a manufacturer, distributor, retailer or health facility”.

How these products per se constitute an SSFFC product is not very clear. These two categories do not necessarily compromise the quality of medicines. The inclusion of diverted product as SSFFC medical product in effect criminalises parallel importation, a flexibility under the Agreement on Trade-related aspects of Intellectual Property Rights (TRIPS).

It also goes against WHO’s Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, which encourages use of flexibilities in the TRIPS Agreement to ensure access to affordable medicine.

The definition of falsified medicine can still be interpreted to include intellectual property infringements especially trademark infringements. Falsified medical product is defined as “A visually imitated medical product and/or its packaging purporting to be licensed by a national medicines regulatory authority (NMRA)”. The term visual imitation is too vague and can include trademark infringement.

Not surprisingly, the surveillance and monitoring project with the above mentioned broad definitions has not provided any information publicly on how many of these alerts were finally verified and classified into the following categories: falsified, substandard, unlicensed, diverted and stolen medical products.

The current study (with its one-page executive summary discussed yesterday on 19 November) is not collecting samples from the field and verifying the data. Instead the study relies on already published studies. The main issue here is that the definition of collecting data varies in each study. Even WHO’s own surveillance mechanism covers diverted and stolen products and if the authors of the study include these as SSFFC medical products the study would necessary come up with an inflated figure like USD 50 billion.

Similarly all substandard medical products would not lead to adverse health consequences. It is only the extreme deviations that have the potential to result in adverse health consequences. It is not entirely clear that the authors of the study would take a public health-oriented approach or just include all out-of-specification products for the health and socioeconomic impact assessment. According to an observer, inclusion of all of the specifications for impact assessment can be termed as “a manufacturing of evidence to serve the purpose of donors”.

This study is based on a proposal first tabled by the US. According to this proposal “the objective of the economic impact study is to provide information and quantify the cost and socioeconomic impact of falsified and substandard medicines and establish the return on investment from strengthening regulatory systems to secure the health products supply chain”.

The study has the following research aims:

Estimate the health and economic cost of poor quality and falsified products (measuring direct and indirect costs) using the available published and unpublished literature and databases.

Determine the costs of implementing, scaling up and supporting alternative options for strengthening regulatory interventions to reduce the health and economic impacts of SSFFC medical products, with the geographical focus of this work depending on the available data.

Determine the cost-effectiveness of specific regulatory interventions (as a health technology) to prevent the economic impact of poor quality products using case studies that are representative of the country or study population

Conduct a cost-benefit/return on investment analysis for alternative options for strengthening regulatory systems

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